An observational study in Multiple Sclerosis, sponsored by Amsterdam UMC, location VUmc. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by Amsterdam UMC, location VUmc · Observational
The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.
This study aims to investigate the effect of an online lifestyle program on the impact of multiple sclerosis (MS) on daily functioning. MS patients will participate in the online lifestyle intervention of Voeding Leeft and will complete online questionnaires at 7 time-points: 3 months before the start of the intervention (run-in), before the start of the intervention (baseline), and 3, 6, 12, 18 and 24 months after the start of the intervention. A subsample (n=200) will also take part in measurements through mobile applications. The investigators hypothesize that the lifestyle program will reduce the impact of MS on the patients' daily functioning.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 900 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with multiple sclerosis (MS) who signed up for the online lifestyle intervention of Voeding Leeft will be asked to participate in this observational study.
Eligibility criteria to participate in the online lifestyle intervention:
Inclusion Criteria:
Exclusion Criteria:
Patients will participate in an online lifestyle program organized by Voeding Leeft, which consists of four main topics: diet, physical activity, relaxation and sleep.
Behavioral: Lifestyle intervention program "Leef! met MS"
The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings.
Multiple Sclerosis Impact Scale (MSIS-29)
Questionnaire that measures the impact of MS on their daily functioning
Time frame: Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
12-item Short Form Health Survey (SF-12)
Questionnaire that measures quality of life
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
EuroQol 5 Dimensions Questionnaire (EQ-5D)
Questionnaire that measures quality of life
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
BMI
BMI in kg/m\^2
Time frame: Assessed at 7 time-points during 27 months Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Waist circumference
Waist circumference in centimeters
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Bristol stool chart
Tool used to indicate stool type
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Medical Consumption Questionnaire (iMCQ)
Questionnaire that measures health-care consumption
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Hospital Anxiety and Depression Scale (HADS)
Questionnaire that measures symptoms of depression and anxiety
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Checklist Individual Strength-20-r (CIS-20)
Questionnaire that measures the level of fatigue
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P)
Questionnaire that measures the level of subjective cognitive complaints
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Medical Outcomes Study Sleep Scale (MOS-ss)
Questionnaire that measures sleep quality
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB))
Questionnaire that measures the level of physical activity
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Perceived stress scale (PSS)
Questionnaire that measures the level of perceived stress
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
iMTA Productivity Cost Questionnaire (iPCQ)
Questionnaire that measures work productivity and the frequency of sick leave
Time frame: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Neurokeys keyboard app
Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology.
Time frame: Continuous measures during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT)
Only in a subsample (n=200); Patients will use the MS sherpa app to perform a smartphone-adapted Symbol Digit Modalities Test (sSDMT) on their mobile phone.
Time frame: Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
MS sherpa app - Smartphone-adapted two-minute walking test
Only in a subsample (n=200); Patients will use the MS sherpa app to perform a two-minute walking test outside.
Time frame: Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
MS sherpa app - questionnaire
Only in a subsample (n=200); Patients will use the MS sherpa app to answer seven questions on a likert-scale (e.g. about pain, stress, energy, memory) within the mobile application.
Time frame: Weekly questionnaire during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Plan to share: Undecided
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Amsterdam UMC, location VUmc